Key component

ST

PR

Legislation and regulation.

ST 1 - ST 11

PR 1 - PR 7

Essential drug selection and drug registration.

ST 12 - ST 18

PR 8 - PR 13

Drug allocation in the health budget/public sector financing policy.

ST 19 - ST 23

PR 14 - PR 18

Public sector procurement procedures.

ST 24 - ST 30

PR 19 - PR 26

Public sector distribution and logistics.

ST 31 - ST 36

PR 27 - PR 29

Pricing policy.

ST 37 - ST 41

PR 30 - PR 32

Information and continuing education on drug use.

ST 42 - ST 50

PR 33 - PR 38

ST1:

Is there an official national drug policy document updated in the past 10 years?

ST2:

Is there drug legislation updated in the past 10 years?

ST3:

Have regulations based on the drug legislation been issued?

ST4:

Is there a drug regulatory authority whose mandate includes registration and inspection?

ST5:

Is there a licensing system to regulate the sale of drugs (wholesalers, pharmacists, retailers)?

ST6:

Are pharmacists legally entitled to substitute generic drugs for brand name products?

ST7:

Are there legal provisions for penal sanctions?

ST8:

Is there a checklist for carrying out inspections in different types of pharmaceutical establishments?

ST9:

Are there any institutions within or outside the country where quality control is carried out?

ST10:

Is the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce used systematically?

ST11:

Are there controls on drug promotion based on regulations and consistent with the WHO Ethical Criteria for Medicinal Drug Promotion?

ST12:

Is there a national essential drugs list (EDL)/formulary using INN officially adopted and distributed countrywide?

ST13:

Is there an official drug committee whose duties include updating the national essential drugs list (EDL)?

ST14:

Has the national essential drugs list (EDL)/formulary been updated and distributed countrywide in the past five years?

ST15:

Do drug donations comply with the national essential drugs list (EDL)?

ST16:

Are there formal procedures for registering drugs?

ST17:

Is there a drug registration committee?

ST18:

Is drug registration renewal required at least every five years?

ST19:

Is the public drug budget spent per year more than 20% of the ministry of health operating budget spent per year for the last three years?

ST20:

Is the public drug budget spent per capita per year more than US$ 1.00 per year for the last three years?

ST21:

Is the public drug budget spent for national hospitals less than 40% of the total public drug budget spent for the last three years?

ST22:

Has the public drug budget spent per capita increased in the last three years?

ST23:

Are there any financing systems in addition to the public drug budget that contribute to the provision of drugs in the public sector?

ST24:

Are drugs usually procured in the public sector through competitive tender?

ST25:

Is there a system for monitoring supplier performance?

ST26:

Is most of the tendering done under international nonproprietary name (INN)?

ST27:

Does the procurement unit receive foreign currency in less than 60 days (from request to release)?

ST28:

Is procurement in the public sector limited to drugs on the national essential drugs list (EDL)?

ST29:

Is the average lead time (from order to receipt at central level) less than eight months?

ST30:

Is procurement based on a reliable quantification of drug needs?

ST31:

Are good storage practices observed in the central procurement/distribution unit and/or major regional warehouses?

ST32:

Is the information recorded on the stockcards for a basket of drugs¹¹ the same as the quantity of stock in store?

ST33:

Are the stocks for a basket of drugs within their expiry dates in the central procurement/distribution unit and/or major regional warehouses?

ST34:

Have all incoming products been physically inspected for the last three deliveries in the central procurement/distribution unit and/or in major regional warehouses?

ST35:

Are only drugs which are on the national essential drugs list (EDL) in stock in the central procurement/distribution unit and/or in major regional warehouses?

ST36:

Are 80% or more of the vehicles of the central procurement/distribution unit and/or major regional warehouses in working condition?

ST37:

Are drug prices regulated in the private sector?

ST38:

Is there at least one major incentive for the private sector to sell essential drugs at low cost?

ST39:

Is the total margin used by wholesalers and retailers less than 35% of the CIF price?

ST40:

Is there a system for monitoring drug prices?

ST41:

Are essential drugs under INN or generic name sold in private drug outlets?

ST42:

Is there a national publication (formulary/bulletin/manual, etc.), revised within the past five years, providing objective information on drug use?

ST43:

Is there a national therapeutic guide with standardized treatments?

ST44:

Is the concept of essential drugs part of the curricula in the basic training of health personnel?

ST45:

Is there an official continuing education system on rational use of drugs for prescribers and dispensers?

ST46:

Is there a drug information unit/centre?

ST47:

Does the drug information unit/centre (or another independent body) provide regular information on drugs to prescribers and dispensers?

ST48:

Are there therapeutic committees in the major hospitals?

ST49:

Are there public education campaigns on drug use?

ST50:

Is drug education included in the primary/secondary school curricula?